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Immersive virtual reality as analgesia for women during hysterosalpingography: study protocol for a randomized controlled trial

机译:止血作品期间孕妇的沉重虚拟现实:随机对照试验的研究方案

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Hysterosalpingography (HSG) is an accepted radiologic diagnostic modality for initial infertility workup, and is generally considered uncomfortable and painful. However, the management of pain related to HSG remains inefficient. As an emerging nonpharmacologic and noninvasive pain control strategy, virtual reality (VR) distraction has been successfully used in areas such as burns, blunt force trauma, hospital-based needle procedures, dental/periodontal procedures, and urological endoscopy patients. This study aims to evaluate the analgesic effect of VR during HSG. A single-center, parallel-group, randomized controlled trial will be carried out in the Radiology Department of Yinchuan Women and Children Healthcare Hospital, Yinchuan. A total of 200 participants who are scheduled for HSG will be enrolled in this study. The participants will be randomized (1:1) into two groups: a VR group and a blank control group. The VR group will receive routine care plus immersive VR intervention and the blank control group will receive routine care. Outcomes will be monitored at baseline, immediately after HSG and 15?min after HSG for each group. The primary outcome is the worst pain score during HSG by a visual analog scale (VAS). The secondary outcomes include: affective pain, cognitive pain, and anxiety during the HSG procedure; worst pain within 15?min after HSG; patient satisfaction and acceptance with pain management; physiological parameters; adverse effects; HSG results; and immersion perception score of the VR system (for the VR condition only). This study will focus on exploring a simply operated, noninvasive and low-cost analgesia during the HSG procedure. The results of this trial will provide data on the feasibility and safety of VR distraction therapy during HSG. Chinese Clinical Trial Register, ChiCTR1900021342. Registered on 16 February 2019.
机译:HysterosalapleAction(HSG)是一种可接受的放射学诊断方式,用于初始不孕次数,通常被认为是不舒服和痛苦的。然而,与HSG相关的疼痛的管理仍然低效。作为一种新兴的非武装和非侵袭性疼痛控制策略,虚拟现实(VR)分心已成功地用于燃烧,钝力创伤,医院的针手术,牙科/牙周癌和泌尿外科检查患者等领域。本研究旨在评估HSG期间VR的镇痛作用。一中心,并联组随机对照试验将在银川妇女和儿童医疗保健医院的放射学系进行。这项研究中,共有200名计划的200名参与者将注册。参与者将被随机(1:1)分为两组:VR组和空白对照组。 VR组将获得常规护理加上沉浸式VR干预,空白对照组将获得常规护理。结果将在基线上监测结果,在HSG和每组HSG后的15?min后立即监测。主要结果是通过视觉模拟量表(VAS)在HSG期间最严重的疼痛评分。二次结果包括:在HSG程序期间情感疼痛,认知疼痛和焦虑; HSG后15岁以下的最严重的疼痛;患者满意度和痛苦管理的接受;生理参数;不利影响; HSG结果;并浸入VR系统的感知得分(仅限VR条件)。本研究将侧重于在HSG程序期间探索简单的操作,非侵入性和低成本的镇痛。该试验的结果将提供关于HSG期间VR分散疗法的可行性和安全性的数据。中国临床试验登记,CHICTR1900021342。 2019年2月16日注册。

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